Genedata Provides First End-to-End Multi-Attribute Method Solution for Characterization and Quality Monitoring of Biopharmaceuticals

Latest release of Genedata Expressionist automates mass spectrometry processes and addresses key biopharma industry requirements for every stage of the MAM workflow

March 11, 2021
Basel, Switzerland

Genedata, the leading provider of enterprise software solutions for biopharmaceutical R&D, today announced the release of Genedata Expressionist^® 15.0, the latest version of the only enterprise platform for streamlining and automating mass spectrometry-based workflows across instruments and analytical processes employed during biopharma R&D.

Representing a major step forward in Genedata’s strategy to spearhead the biopharma industry’s adoption of the Multi-Attribute-Method (MAM), this latest release provides a complete end-to-end solution for the entire MAM workflow — from upstream in-depth characterization to downstream targeted critical quality attribute (CQA) monitoring — on a single integrated software platform.

Developed in close partnerships with innovative leaders in the biopharmaceutical industry, the release:

• Introduces an all-new solution to automate the monitoring of CQAs;
• Streamlines and simplifies method transfer from Development to Manufacturing and QC;
• Enables up- and downstream data integration to automate the entire MAM process.

The innovative data processing strategy implemented in Genedata Expressionist now includes a novel Extracted Ion Chromatogram (XIC)-based approach that delivers easy-to-use, highly robust, and accurate targeted Critical Quality Attribute (CQA) quantification, which is critical in automating quality monitoring processes in standardized environments.

Genedata Expressionist 15.0 is the result of continuous product innovation and expansion, and now offers customers rapid deployment of ready-to-use configurable workflows for each stage of the MAM process; from in-depth characterization, through untargeted quality attribute identification and advanced detection of new peaks and unknowns, to targeted CQA monitoring.

“By digitalizing complex R&D workflows, Genedata increases efficiencies in data analysis, improves data quality, and mitigates risks in our customers’ processes,” stated Othmar Pfannes, Ph.D., CEO of Genedata. “The end-to-end MAM solution provided by Genedata Expressionist 15.0 is a further demonstration of Genedata’s focus on addressing major bottlenecks from Research and Development to QC in close collaboration with our rapidly growing customer base in the biopharma industry.”